These are the details for the profile Slovenian contract and research company specialised in regulatory and clinical trials services is offering its services.
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Slovenian contract and research organization that performs full-scope of clinical trials operations for pharmaceutical, biotechnology research and development companies and manufacturers is offering its services to potential partners on the European and Balkan market and is interested in cooperation in the form of a services agreement.
Internationally oriented company from Slovenia established in 2013 with full competence to give support in clinical operations, regulatory, and wholesale services for medicinal products, medical devices, food supplements, and cosmetics in the territory of South East Europe, Austria, Latvia, Lithuania, Estonia, Israel, Japan and other Asian countries. They collaborates with many major pharmaceutical companies, all major sites in Slovenia, and physicians who are key opinion leaders in their field of expertise and provide integrated regulatory services for human and veterinary medicines, medical devices, food supplements and cosmetics
Their support client saves money because there's no need to establish branch office`s. The company can act as the local marketing authorization holder and authorized agent specialized in the sale of client's products. The company establishes and maintains pharmacovigilance system(s), there's no need to employ specialized profiles (i.e. regulatory specialist, clinical research associate, qualified person for pharmacovigilance, auditor of ISO quality management system for medical devices, etc.), the client has access to specialized databases that can otherwise present high costs.
The company has an established network of connections and experience with potential customers and regulatory authorities and communicates with notified bodies, prepares regulatory and clinical operations strategy, and helps with logistics distribution of products.
The company strives for professional and quality services, and strictly adheres to the agreed timelines.
Their offices are located in the reputable business building in the capital of Slovenia, Ljubljana, 5 km from the city centre, and with easy access to highways (within 0,5 km).
The company offers its services to potential business partners (Contract research organization, research & development companies, pharmaceutical companies, biotechnology companies, manufacturers of all classes of medical devices, food supplements and cosmetics) and is interested in cooperation in the form of Services Agreement.
- Long lasting experience in the field of clinical trials and regulatory requirements in a wider geographical area.
- Experience in most therapeutic fields.
- Knowledge of global and local regulation, and local marketing requirements.
Established connections with regulatory authorities, notified bodies, and key opinion leaders
- no need for the Client to establish local branch office
- no need for the Client to establish and maintain pharmacovigilance system
- No need for the Client to employ specialized profiles, i.e. regulatory specialist, clinical research associate, qualified person for pharmacovigilance, auditor of ISO Quality Management System for Medical Devices, etc..
- The company acts as Marketing Authorisation Holder and/or Agent specialized in the sale of Client's products
The company is established with full Quality and SOP System in place, and employs, or is connected to experts in the fields of its services.
Intellectual Property Rights of all parties are always protected by signed Business and Confidentiality Agreements.
Slovenian company specialised in clinical operations, regulatory, and wholesale services for medicinal products, medical devices, food supplements, and cosmetics is offering its services to potential partners (Contract research organizations, research & development companies, pharmaceutical companies, biotechnology companies, manufacturers of all classes of medical devices, manufacturer of food supplements, manufacturer of cosmetics and is interested in cooperation in the form of Services Agreement.